Atralin

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under prescribing
conditions, adverse reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in the clinical trials of another drug and
may not reflect the rates observed in practice.

In two randomized, controlled trials, 674 subjects
received treatment for up to 12 weeks with Atralin Gel [see Clinical Trials].
In these studies, 50% of the subjects who were treated with Atralin Gel
reported one or more adverse reactions; 30% of the subjects reported
treatment-related adverse reactions. In the vehicle group, 29% of the 487
randomized subjects reported at least one adverse reaction; 5% of the subjects
reported events that were treatment-related. There were no serious,
treatment-related adverse reactions reported by subjects in any of the
treatment groups.

Selected adverse reactions that occurred in at least 1%
of subjects in the two trials combined are shown in Table 1 (below). Most
skin-related adverse reactions first appear during the first two weeks of
treatment with Atralin Gel, and the incidence rate for skin-related reactions
peaks around the second and third week of treatment. In some subjects the
skin-related adverse reactions persists throughout the treatment period.

Table 1: Number of Subjects with Selected Adverse
Reactions (Occurring in At Least 1% of Subjects)

Event

Atralin Gel
(n = 674)

Vehicle Gel
(n = 487)

Dry Skin

109 (16%)

8 (2%)

Peeling/Scaling/ Flaking Skin

78 (12%)

7 (1%)

Skin Burning Sensation

53 (8%)

8 (2%)

Erythema

47 (7%)

1 ( < 1%)

Pruritus

11 (2%)

3 (1%)

Pain of Skin

7 (1%)

0 (0%)

Sunburn

7 (1%)

3 (1%)

Postmarketing Experience

The following adverse reactions
have been identified during post-approval use of Atralin Gel. Because these
reactions are reported voluntarily from a population of uncertain size, it is
not always possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.

Temporary hyper-or hypopigmentation has been reported
with repeated application of tretinoin.